Slide 1: LPCN 1154 Oral Neuroactive Steroid for Depression Disorders: Topline Results
LIPOCIN= ENHANCING HEALTH LPCN 1154 Ojal Neuroactive Steroid for Depression Disorders Topline Results PK Bridge Clinical Study Conference Call May 16, 2023
Slide 2: Forward-Looking Statements
Forward-Looking Statements This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding our product development efforts, the anticipated u
Slide 3: Strong Pharmacological Rationale
LPCN 1154 Strong Pharmacological Rationale Mec sm of Ac Brexanolone is a positive Allosteric Modulator (PAM) of the GABA, receptor Hormonal changes leading to GABA dysfunction are common in depression and pregnancy ipspentetsu etupsyeosrusbeumleh GABA Receptor Substrates Binding GABA Soszostens aa 6
Slide 4: Validated Proprietary Lip'ral Technology Platform
Validated Proprietary Lip’ral Technology Platform Oral Enablement of Brexanolone ura lan Achieved Relevant Systemic Levels - a how + Fioome = BR agrees in Phase 1 Study asain Sm Observed PK Profile Post Oral Administration =. 5 70 2 ee | 25 60 2. i S21) 52 i Pos S85 30 go 5 & 20 ‘Section of Gt ‘Inso
Slide 5: 1154 for Depression Disorders
LPCN 1154 for Depression Disorders New Treatment Paradigm for Depression Significant Unmet Needs in Depression Disorders: Per NIMH, in 2020, an estimated 21.0 million (8.4%) adults in the US had at least one major depressive episode. *TRD: Prevalence ~2.8 million in US? “The prevalence of comorbid a
Slide 6: Postpartum Depression (PPD)
Postpartum Depression (PPD) A Major Depressive Disorder Within Weeks of Childbirth » Estimated patients in the U.S. with PPD: ~500K annually’ » The prevalence of adolescent-onset PPD is two-folds higher than adult-onset PPD? » Suicide/suicide ideation, a significant concern: Suicide is a leading cau
Slide 7: Limitations of Current Pharmacological Treatment Modality for PPD
Limitations of Current Pharmacological Treatment Modality for PPD PPD — A Substantial Opportunity SSRIs/SNRIs Injectable Brexanolone (Not approved for PPD indication, off label use) Slow onset of antidepressant action — may take 4-6 weeks! Treatment duration — acute for 6-8 weeks, followed by 4-9 mo
Slide 8: 1154: A Potential Preferred Option for Rapid Relief in PPD
LPCN 1154: A Potential Preferred Option for Rapid Relief in PPD The Days After Childbirth are a Critical Time Period for the Care of Both Mother and Newborn Product Candidate Attributes + Monotherapy or add-on therapy for patients (including adolescents) with unresolved symptoms + Convenient oral fo
Slide 9: 1154: Pilot PK Bridge Study
LPCN 1154: Pilot PK Bridge Study Rationale and Clinical Design FDA agrees with Lipocine's proposal to establish efficacy through a pharmacokinetic (PK) bridge to IV brexanolone An open-label, randomized, three-period, 3-arm partial crossover study to compare the PK of oral LPCN 1154 (brexanolone) an
Slide 10: IV Brexanolone Demonstrated Efficacy with Two Dosing Regimens
IV Brexanolone Demonstrated Efficacy with Two Dosing Regimens rarget Dosage": a sO" Placebo —— ZULRESSO 90 meg/kg/hour —2— ZULRESSO 60 megikgihour E oo + 2 8 3 4 g 60 i 10 & 3 i Endot pasion g i ce 7 g 30 a5 . aT 2 ~— 7 aT — o 3 8 12 16 20 2 26 32 36 40 a4 48 52 58 60 » PEPPPRPaOSs a i Hour Sos 8 Re
Slide 11: Pharmacokinetic Results
Pharmacokinetic Results Dosing Regimen Identified for Confirmatory PK Study Ratios (%) of geometric mean LPCN 1154 regimens vs IV brexanolone regimens DRivs DRivs DR2vs DR 2vs een IV 60 pg* 1V 90 ng IV 60 pg* IV 90 pg AUC. 17% 106% 83% Cmax 114% 68% 134% 79% + DR 1 resulted in comparable brexanolone
Slide 12: 1154 Was Well-Tolerated
LPCN 1154 Was Well-Tolerated Consistent with Prior LPCN 1154 Clinical Experience All AEs were mild or moderate in severity e AEs were similar across trial arms e Majority (63%) AEs were venipuncture site pain (PK draws) or venipuncture site reactions (IV infusions) e No Serious Adverse Events were o
Slide 13: Streamlined Pathway to NDA Submission
LPCN 1154 Streamlined Pathway to NDA Submission Initiate 2H 2023 Phase 1 Pilot PK Bridge Study PK Pivotal Study Successful single dose study completed Positive Topline Results Confirmatory trial to establish Established feasibility of oral administration efficacy for NDA submission* *Laboing sues ma
Slide 14: 1154: A New Paradigm in Oral Treatment for Depression
LPCN 1154: A New Paradigm in Oral Treatment for Depression Conclusions e Differentiated product attributes address unmet needs e Oral, rapid relief, short treatment duration, high remission rate* e Brexanolone is an approved neuroactive steroid for depression with validated unique mechanism of actio